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A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by The George Washington University Biostatistics Center
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:
NCT01990612
First received: November 15, 2013
Last updated: August 14, 2017
Last verified: August 2017
  Purpose
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Condition Intervention
Labor and Delivery Procedure: Elective Induction of Labor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

Further study details as provided by The George Washington University Biostatistics Center:

Primary Outcome Measures:
  • composite of severe neonatal morbidity and perinatal mortality [ Time Frame: delivery ]

    Includes any one of:

    • Antepartum, intrapartum, or neonatal death
    • Intubation, CPAP, or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within the first 72 hours
    • Apgar ≤ 3 at 5 minutes
    • Neonatal encephalopathy as defined by Shankaran et al.
    • Seizures
    • Sepsis (presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an X-ray confirming infection)
    • Pneumonia confirmed by X-ray or positive blood culture.
    • Meconium aspiration syndrome
    • Birth trauma (bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy)
    • Intracranial hemorrhage (intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma)
    • Hypotension requiring pressor support


Secondary Outcome Measures:
  • Cesarean delivery and indication [ Time Frame: delivery ]
  • Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas [ Time Frame: delivery ]
  • Operative vaginal delivery and indication [ Time Frame: delivery ]
  • Chorioamnionitis, defined as a clinical diagnosis before delivery [ Time Frame: before delivery ]
  • Third or fourth degree perineal laceration [ Time Frame: delivery ]
  • Maternal death [ Time Frame: delivery ]
  • Admission to intensive care unit (ICU) [ Time Frame: delivery ]
  • Preeclampsia/gestational hypertension [ Time Frame: before delivery ]
  • Postpartum hemorrhage [ Time Frame: delivery ]

    defined as any of the following:

    • Transfusion
    • Non-elective hysterectomy
    • Use of two or more uterotonics other than oxytocin
    • Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade
    • Curettage

  • Interval from randomization to delivery [ Time Frame: delivery ]
  • Gestational age at delivery [ Time Frame: delivery ]
  • Maternal postpartum infection [ Time Frame: delivery ]

    Defined as any of the following:

    • Clinical diagnosis of endometritis
    • Wound reopened for hematoma, seroma, infection or other reasons
    • Cellulitis requiring antibiotics
    • Pneumonia
    • Pyelonephritis
    • Bacteremia - unknown source
    • Septic pelvic thrombosis

  • Maternal venous thromboembolism [ Time Frame: delivery ]
    Deep venous thrombosis or pulmonary embolism

  • Neonatal birth weight [ Time Frame: delivery ]
  • Duration of respiratory support [ Time Frame: delivery ]
    including ventilator, CPAP, high-flow nasal cannula (HFNC)

  • Cephalohematoma [ Time Frame: delivery ]
  • Shoulder dystocia [ Time Frame: delivery ]
  • Transfusion of blood products or blood [ Time Frame: delivery ]
  • Hyperbilirubinemia requiring phototherapy or exchange transfusion [ Time Frame: delivery ]
  • Hypoglycemia [ Time Frame: delivery ]
    glucose < 35 mg/dl and requiring IV therapy

  • Admission to neonatal intensive care unit (NICU) or intermediate care unit [ Time Frame: delivery ]
  • Number of hours on the labor and delivery unit [ Time Frame: delivery ]
  • Maternal postpartum length of hospital stay [ Time Frame: after delivery ]
  • Neonatal length of hospital stay [ Time Frame: delivery ]

Estimated Enrollment: 6000
Study Start Date: March 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Procedure: Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.

Detailed Description:
Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous - no previous pregnancy beyond 20 weeks
  2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

  1. Project gestational age at date of first ultrasound is > 20 weeks 6 days
  2. Plan for induction of labor prior to 40 weeks 5 days
  3. Plan for cesarean delivery or contraindication to labor
  4. Breech presentation
  5. Signs of labor (regular painful contractions with cervical change)
  6. Fetal demise or known major fetal anomaly
  7. Heparin or low-molecular weight heparin during the current pregnancy
  8. Placenta previa, accreta, vasa previa
  9. Active vaginal bleeding greater than bloody show
  10. Ruptured membranes
  11. Cerclage in current pregnancy
  12. Known oligohydramnios, defined as AFI < 5 or MVP < 2
  13. Fetal growth restriction, defined as EFW < 10th percentile
  14. Known HIV positivity because of modified delivery plan
  15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
  16. Refusal of blood products
  17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
  18. Delivery planned elsewhere at a non-Network site
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990612

Contacts
Contact: Uma Reddy, MD, MPH 301-496-1074 uma.reddy@nih.gov

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262    stacylharris@uabmc.edu   
Principal Investigator: Alan TN Tita, MD         
United States, California
Stanford University Active, not recruiting
Stanford, California, United States, 94305-5317
United States, Colorado
University of Colorado Active, not recruiting
Denver, Colorado, United States, 80045
United States, Illinois
Northwestern University-Prentice Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN BSN CCRC    312-503-3200    g-mallett@northwestern.edu   
Principal Investigator: William Grobman, MD         
United States, New York
Columbia University-St. Luke's Hospital Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, MSN    212-305-4348    sb1080@columbia.edu   
Principal Investigator: Cynthia Gyamfi, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M Thorp, Jr., MD         
Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533    wdalton@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN, BSN    614-685-3229    anna.bartholomew@osumc.edu   
Principal Investigator: Catalin S Buhimschi, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Hammond, BSN RN    215-662-2657    mary.hammond@uphs.upenn.edu   
Principal Investigator: Samuel Parry, MD         
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS RN    412-641-4072    mbickus@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, MD MS         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RNC    401-274-1122    dallard@wihri.org   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas Active, not recruiting
Dallas, Texas, United States, 75235-9032
University of Texas - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN BSN    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Suneet Chauhan, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN    801-585-7645    Kim.Hill@hsc.utah.edu   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Uma Reddy, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth Thom, PhD The George Washington University Biostatistics Center
Study Chair: William Grobman, MD Northwestern University
  More Information

Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01990612     History of Changes
Other Study ID Numbers: HD36801-ARRIVE
UG1HD027869 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
UG1HD034116 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD068258 ( U.S. NIH Grant/Contract )
UG1HD068268 ( U.S. NIH Grant/Contract )
Study First Received: November 15, 2013
Last Updated: August 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.

Keywords provided by The George Washington University Biostatistics Center:
Induction of labor
Expectant management of labor
39 weeks gestation

ClinicalTrials.gov processed this record on September 21, 2017